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Background. Accurate prediction of patient survival from the time of starting renal replacement therapy (RRT) is desirable, but previously published predictive models have low accuracy. We have attempted to overcome limitations of previous studies by conducting an ambidirectional inception cohort study in patients on RRT from centres throughout Europe. A conventional multivariate regression (MVR) model, a self-learning rule-based model (RBM) and a simple co-morbidity score [the Charlson score modified for renal disease (MCS)] were compared.Methods. In 1996, all 3640 dialysis centres registered with the ERA-EDTA were invited to identify all patients on RRT for end-stage renal failure (ESRF) who died during the 28 days of February 1997 (training cohort) and all patients who started RRT in the same period (validation cohort). Fifty-four clinical and laboratory variables from the time of starting RRT were collected in both cohorts using a two-page questionnaire. The data from the training cohort were given to statisticians at the Amsterdam Academic Medical Centre to create the MVR model and to engineers in Strathclyde University to create the RBM. They were then given the baseline data from patients in the validation cohort to predict how long each patient would survive. Follow-up questionnaires were sent to the centre of each patient in the validation cohort to determine actual survival.Results. A total of 2310 patients from 793 centres in 37 countries in the ERA-EDTA area were used to construct and validate the models. For predicting 1-year survival, the RBM had the highest positive predictive value (PPV) (84.2%), the MVR model had the highest negative predictive value (NPV) (47%) and the RBM had the highest likelihood ratio (1.59). For predicting 5-year survival, the MCS had the highest PPV (79.4%), the RBM had the highest NPV (74.3%) and the MCS had the highest likelihood ratio (7.0). The proportion of explained variance in survival for MCS, MVR and RBM was 14.6, 12.9 and 3.95%, respectively.Conclusion. Using the ambidirectional inception cohort design of this ERA-EDTA Registry survey, we have been able to create and validate two novel instruments to predict survival in patients starting RRT and compare them with a simple scoring model. The models tended to predict 5-year survival with more accuracy than 1-year survival. Examples of potential applications include informing clinical decision making about the likely benefit of starting RRT and listing for transplantation, adjusting for baseline risk in comparative studies and identifying specific risk groups to participate in clinical trials. [ABSTRACT FROM AUTHOR]

Background. UK native renal biopsy incidence is unknown. Biopsy registries in other countries indicate that the incidence of renal biopsy varies widely. Indications for renal biopsy are largely opinion based. Methods. The Scottish Renal Biopsy Registry aimed to analyse the incidence of native renal biopsy in Scotland and examine indications and diagnoses obtained where practice varied widely. Results. Consecutive native adult renal biopsies performed in eight of the nine Scottish regions that include 82.4% of the population between 2002 and 2006 were examined. A total of 2480 native renal biopsies were performed equating 126.3 biopsies per million population per year (PMP/year). A total of 56.9% of patients were male, mean age 55.6 years (SD 1.3). The centres varied widely, from a lowest mean annual incidence of 65.8 PMP/year in Fife to the highest of 170.7 PMP/year in Tayside. The prospectively recorded indications and diagnoses were compared between Greater Glasgow, Clyde and Forth Valley (GC&FV) (population 1.56 million, 101.6 biopsies PMP/year) and Tayside (population 0.39 million, 177.4 biopsies PMP/year). Differing incidence of renal biopsy in these regions was mainly explained by patients with proteinuria and preserved renal function in the absence of nephrotic syndrome (19.2 PMP/year in GC&FV versus 60.8 PMP/year in Tayside), probably due to variation in nephrologists’ opinion about the utility of biopsy for this indication. Tayside diagnosed more primary glomerulopathies, diabetic nephropathy and chronic ischaemia than GC&FV. Conclusions. We have demonstrated wide regional variability in incidence of native renal biopsy within a single country, with analysis suggesting that this is mainly explained by uncertainty about the utility of renal biopsy for patients with proteinuria and preserved renal function. Further studies are required to determine the value of renal biopsy in this setting. [ABSTRACT FROM AUTHOR]

Although randomised controlled trials (RCT) are considered the optimal form of evidence, there are relatively few in surgery. Surgical RCT are particularly likely to be discontinued with poor recruitment cited as a leading reason. Surgical RCT present challenges over and above those seen in drug trials as the treatment under study may vary between procedures, between surgeons in one unit, and between units in multi-centred RCT. The most contentious and debated area of vascular access remains the role of arteriovenous grafts, and thus the quality of the data that is used to support opinions, guidelines and recommendations is critical. The aim of this review was to determine the extent of variation in the planning and recruitment in all RCT involving AVG. The findings of this are stark: there have been only 31 RCT performed in 31 years, the vast majority of which exhibited major limitations severe enough to undermine the results. This underlines the need for better quality RCT and data, and further inform the design of future studies. Perhaps most fundamental is the planning for a RCT that accounts for the intended population, the uptake of a RCT and the attrition for the significant co-morbidity in this population., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Introducing new procedures and challenging established paradigms requires well-designed randomised controlled trials (RCT). However, RCT in surgery present unique challenges with much of treatment tailored to the individual patient circumstances, refined by experience and limited by organisational factors. There has been considerable debate over the outcomes of arteriovenous grafts (AVG) compared to AVF, but any differences may reflect differing practice and potential variability. It is essential, therefore, when considering an RCT of a novel surgical procedure or device that quality assurance (QA) is defined for both the new approach and the comparator. The aim of this systematic review was to evaluate the QA standards performed in RCT of AVG using a multi-national, multi-disciplinary approach and propose an approach for future RCT., Method: The methods of this have been previously registered (PROSPERO: CRD420234284280) and published. In summary, a four-stage review was performed: identification of RCT of AVG, initial review, multidisciplinary appraisal of QA methods and reconciliation. QA measures were sought in four areas - generic, credentialing, standardisation and monitoring, with data abstracted by a multi-national, multi-speciality review body., Results: QA in RCT involving AVG in all four domains is highly variable, often sub-optimally described and has not improved over the past three decades. Few RCT established or defined a pre-RCT level of experience, none documented a pre-trial education programme, or had minimal standards of peri-operative management, no study had a defined pre-trial monitoring programme, and none assessed technical performance., Conclusion: QA in RCT is a relatively new area that is expanding to ensure evidence is reliable and reproducible. This review demonstrates that QA has not previously been detailed, but can be measured in surgical RCT of vascular access, and that a four-domain approach can easily be implemented into future RCT., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Aims: To assess retrospectively the association between histopathological lesions on renal biopsy and subsequent impairment of renal function across the spectrum of kidney diseases and to explore the influence of immunosuppressive therapy within the first 6 months after biopsy on this association., Methods and Results: Clinical data from 488 adult patients having a renal biopsy reported at a single centre from 2017 to 2019 were obtained during a median follow-up period of 786 days. Seventeen semi-quantitative histology parameters were recorded at the time of biopsy, 14 of which were suitable for assessment of association with loss of eGFR by multivariable Cox regression analysis, measurement of eGFR slope and measurement of eGFR 12 months after biopsy. A widely used histopathological chronicity score was also assessed. Clinical baseline variables including prescription of immunosuppression were recorded. Seven of 14 histology parameters: mesangial matrix expansion, global glomerulosclerosis, tubular atrophy, interstitial fibrosis, arteriolosclerosis, mesangial hypercellularity and acute tubular injury; and the chronicity score, predicted loss of kidney function by all three measures. Prescription of immunosuppression was more likely in patients with active inflammatory pathology and less likely in patients with chronic fibrotic pathology, and was associated with reduced risk of loss of eGFR., Conclusions: This retrospective study demonstrates the prognostic significance and complex relationship with immunosuppression of routinely reported histopathological variables in patients having native kidney biopsies, across the spectrum of kidney diseases. It provides useful information for renal biopsy prognostication and design of retrospective studies, including machine learning models., (© 2023 John Wiley & Sons Ltd.)

Background: The role of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in the management glomerular/systemic autoimmune diseases with proteinuria in real-world clinical settings is unclear., Methods: This is a retrospective, observational, international cohort study. Adult patients with biopsy-proven glomerular diseases were included. The main outcome was the percentage reduction in 24-h proteinuria from SGLT2i initiation to 3, 6, 9 and 12 months. Secondary outcomes included percentage change in estimated glomerular filtration rate (eGFR), proteinuria reduction by type of disease and reduction of proteinuria ≥30% from SGLT2i initiation., Results: Four-hundred and ninety-three patients with a median age of 55 years and background therapy with renin-angiotensin system blockers were included. Proteinuria from baseline changed by -35%, -41%, -45% and -48% at 3, 6, 9 and 12 months after SGLT2i initiation, while eGFR changed by -6%, -3%, -8% and -10.5% at 3, 6, 9 and 12 months, respectively. Results were similar irrespective of the underlying disease. A correlation was found between body mass index (BMI) and percentage proteinuria reduction at last follow-up. By mixed-effects logistic regression model, serum albumin at SGLT2i initiation emerged as a predictor of ≥30% proteinuria reduction (odds ratio for albumin <3.5 g/dL, 0.53; 95% CI 0.30-0.91; P = .02). A slower eGFR decline was observed in patients achieving a ≥30% proteinuria reduction: -3.7 versus -5.3 mL/min/1.73 m2/year (P = .001). The overall tolerance to SGLT2i was good., Conclusions: The use of SGLT2i was associated with a significant reduction of proteinuria. This percentage change is greater in patients with higher BMI. Higher serum albumin at SGLT2i onset is associated with higher probability of achieving a ≥30% proteinuria reduction., (© The Author(s) 2023. Published by Oxford University Press on behalf of the ERA.)

Introduction: Decisions regarding the optimal vascular access for haemodialysis patients are becoming increasingly complex, and the provision of vascular access is open to variations in systems of care as well as surgical experience and practice. Two main surgical options are recognised: arteriovenous fistula and arteriovenous graft (AVG). All recommendations regarding AVG are based on a limited number of randomised controlled trials (RCTs). It is essential that when considering an RCT of a surgical procedure, an appropriate definition of quality assurance (QA) is made for both the new approach and the comparator, otherwise replication of results or implementation into clinical practice may differ from published results. The aim of this systematic review will be to assess the methodological quality of RCT involving AVG, and the QA measures implemented in delivering interventions in these trials., Methods and Analysis: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be followed. A systematic search will be performed of the MEDLINE, Embase and Cochrane databases to identify relevant literature. Studies will be selected by title and abstract review, followed by a full-text review using inclusion and exclusion criteria. Data collected will pertain to generic measures of QA, credentialing of investigators, procedural standardisation and performance monitoring. Trial methodology will be compared against a standardised template developed by a multinational, multispecialty review body with experience in vascular access. A narrative approach will be taken to synthesise and report data., Ethics and Dissemination: Ethical approval is not required as it is a protocol for a systematic review. Findings will be disseminated through peer-reviewed publications and conference presentations, with the ultimate aim of providing recommendations for future RCT of AVG design., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Renal artery stenosis manifests as poorly-controlled hypertension, impaired renal function or pulmonary oedema, therefore the success of treatment is dependent on indication. This study aims to determine the outcomes of patients undergoing renal artery stenting (RASt) based on therapeutic aim compared to criteria used in the largest randomised trial. Retrospective case-note review of patients undergoing RASt between 2008-2021 (n = 74). The cohort was stratified by indication for intervention (renal dysfunction, hypertension, pulmonary oedema) and criteria employed in the CORAL trial, with outcomes and adverse consequences reported. Intervention for hypertension achieved significant reduction in systolic blood pressure and antihypertensive agents at 1 year (median 43 mmHg, 1 drug), without detrimental impact on renal function. Intervention for renal dysfunction reduced serum creatinine by a median 124 μmol/L, sustained after 6 months. Intervention for pulmonary oedema was universally successful with significant reduction in SBP and serum creatinine sustained at 1 year. Patients who would have been excluded from the CORAL trial achieved greater reduction in serum creatinine than patients meeting the inclusion criteria, with equivalent blood pressure reduction. There were 2 procedure-related mortalities and 5 procedural complications requiring further intervention. 5 patients had reduction in renal function following intervention and 7 failed to achieve the intended therapeutic benefit. Renal artery stenting is effective in treating the indication for which it has been performed. Previous trials may have underestimated the clinical benefits by analysis of a heterogenous population undergoing a procedure rather than considering the indication, and excluding patients who would maximally benefit., (© 2022. The Author(s).)

Background: Reports of HLA incompatible (HLAi) kidney transplant outcomes are inconclusive, especially in the context of lower level Donor Specific Antibodies (DSA)., Methods: Multi-centre national cohort study of HLAi kidney transplant recipients matched in 1:2 ratio with HLA compatible (HLAc) kidney transplant recipients. HLAi defined as DSA identified by Luminex. Antibody mediated rejection (AMR) and transplant-survival were analysed using Kaplan-Meier plots. Propensity score (PS) matching was used to compare recipient and transplant survival between groups., Results: We included 61 HLAi and 122 HLAc recipients; mean age 46 years; 60% female. MFI T0 : 3327 (IQR 1352-6458), 23 (38%) were Flow cytometry crossmatch positive (FC-XM POS ). DSA POS /FC-XM POS transplantation carried an increased risk of AMR at 1 year (52%) compared to DSA POS /FC-XM NEG (27%) and HLAc (0%). Unadjusted death censored graft loss at 3 years was 13% (HLAi) and 8% (HLAc). Three-year patient survival was 95% in HLAc, 84% in DSA POS /FC-XM NEG and 69% in DSA POS /FC-XM POS recipients; 58% of HLAi deaths were infection-related. HLA incompatibility was associated with a decreased 3-year survival in our PS-matched cohort., Conclusion: In kidney transplantation, DSA and positive FC-XM carries an increased risk of AMR. Despite inferior transplant and survival outcomes compared to HLAc transplantation, it remains a realistic option for highly sensitized patients facing prolonged waiting times and reduced survival on dialysis., (© 2022 Asian Pacific Society of Nephrology.)

Background: The acute and long-term effects of severe acute respiratory syndrome coronavirus 2 infection in individuals with GN are still unclear. To address this relevant issue, we created the International Registry of COVID-19 infection in GN., Methods: We collected serial information on kidney-related and -unrelated outcomes from 125 GN patients (63 hospitalized and 62 outpatients) and 83 non-GN hospitalized patients with coronavirus disease 2019 (COVID-19) and a median follow-up period of 6.4 (interquartile range 2.3-9.6) months after diagnosis. We used logistic regression for the analyses of clinical outcomes and linear mixed models for the longitudinal analyses of eGFR. All multiple regression models were adjusted for age, sex, ethnicity, and renin-angiotensin-aldosterone system inhibitor use., Results: After adjustment for pre-COVID-19 eGFR and other confounders, mortality and AKI did not differ between GN patients and controls (adjusted odds ratio for AKI=1.28; 95% confidence interval [CI], 0.46 to 3.60; P =0.64). The main predictor of AKI was pre-COVID-19 eGFR (adjusted odds ratio per 1 SD unit decrease in eGFR=3.04; 95% CI, 1.76 to 5.28; P <0.001). GN patients developing AKI were less likely to recover pre-COVID-19 eGFR compared with controls (adjusted 6-month post-COVID-19 eGFR=0.41; 95% CI, 0.25 to 0.56; times pre-COVID-19 eGFR). Shorter duration of GN diagnosis, higher pre-COVID-19 proteinuria, and diagnosis of focal segmental glomerulosclerosis or minimal change disease were associated with a lower post-COVID-19 eGFR., Conclusions: Pre-COVID-19 eGFR is the main risk factor for AKI regardless of GN diagnosis. However, GN patients are at higher risk of impaired eGFR recovery after COVID-19-associated AKI. These patients (especially those with high baseline proteinuria or a diagnosis of focal segmental glomerulosclerosis or minimal change disease) should be closely monitored not only during the acute phases of COVID-19 but also after its resolution., Competing Interests: O. Bestard reports patents and inventions with Oxford Immunotec and is associate editor of Transplant International and Frontiers in Immunology. A. Bruchfeld reports consultancy agreements with AstraZeneca, Chemocentryx, Fresenius, and Merck; a research grant from AstraZeneca; honoraria from Bayer, Chemocentryx, Fresenius, Merck, and Vifor; and is a member of the ERA-EDTA scientific advisory board 2018–2024, chair of the ERA-EDTA Immunonephrology Working Group, and vice-chair of the Swedish Renal Fund. G. Comai reports honoraria from Alexion, Astellas, and Novartis. P. Cravedi reports honoraria as an advisor for Chinook Therapeutics and is associate editor for the Journal of Nephrology and the American Journal of Transplantation. G. Fernandez Juarez reports research funding from Instituto Salud Calos III and honoraria from Alexion and GSK. E. Fiaccadori is on the editorial board of the Journal of Nephrology and Blood Purification and is a member of the Italian Society of Nephrology and the European Society of Parenteral and Enteral Nutrition. O. Flossmann reports consultancy agreements with Vifor Pharma has other interests/relationships with the British Medical Association, European Vasculitis Society, Renal Association (UK), Royal College of Physicians London, and UK Ireland Vasculitis Society. C. García-Carro reports consultancy agreements with Astellas, AstraZeneca, Boehringer Ingelheim Lilly, Esteve, Novartis and Baxter, Novo Nordisk, and Otsuka; honoraria from Astellas, AstraZeneca, Boehringer Ingelheim Lilly, Esteve, Novartis and Baxter, Novo Nordisk, and Otsuka; and is a scientific advisor for or member of AstraZeneca, Boehringer Ingelheim Lilly, Mundipharma, and Novo Nordisk. M. Griffith reports honoraria from Retrophin’s advisory board. A. J. Hamilton is on the editorial board of the Journal of Kidney Care and is a member of the SONG-Kids Life Participation Expert Working Group. T. Leach reports honoraria from Janssen for conference attendance in 2012 and is a scientific advisor to the National Institute for Health and Care Excellence. L. Lightstone reports consultancy agreements with Achillion, Alexion, AstraZeneca, Aurinia, BMS, GSK, Kezar, Novartis, Pfizer, and Roche; honoraria from Alexion, AstraZeneca, BMS, GSK, and Pfizer; is a scientific advisor or member of EU Exec Lupus Nephritis Trials Network; is on the advisory board of Nature Reviews Nephrology; participates in a speakers’ bureau for Alexion and GSK; is a trustee of Kidney Research UK 2018–2022; is an executive member of the International Society of Nephrology 2021–2023; is deputy chair of Western Regional Board of the International Society of Nephrology; and is a clinical expert representing the Renal Association response to NICE on STA for belimumab in lupus 2020–2021. U. Maggiore reports consultancy agreements with Biotest, Chiesi, GSK, Hansa, Novartis, Sandoz, and Takeda. J. Manrique is a scientific advisor for or member of AstraZeneca, Boehringer, and Viphor Pharma. E. Morales reports consultancy agreements with Alexion, Celgene, Viphor Fresenius, and Vifor Pharma. J.A. Niño-Cruz reports research funding from Pfizer Scientific Institute and participates in a speakers’ bureau for Takeda and Roche. A. Ortiz reports consultancy agreements with Retrophin and Sanofi Genzyme; research funding from AstraZeneca, Mundipharma, and Sanofi Genzyme; honoraria from Advicciene, Alexion, Amgen, Amicus, Astellas, AstraZeneca, Bayer, Chiesi, Fresenius Medical Care, Idorsia, Kyowa Kirin, Menarini, Otsuka, Sanofi Genzyme, and Vifor Fresenius Medical Care Renal Pharma; is a member of the Spanish Society of Nephrology; is editor-in-chief of the Clinical Kidney Journal; is on the editorial boards of the Journal of Nephrology, Journal of the American Society of Nephrology, and Peritoneal Dialysis International; is a member of SOMANE and ERA Councils; is on the board of directors for IIS-Fundacion Jimenez Diaz UAM; is on the scientific advisory board of the Dutch Kidney Foundation; honoraria listed above are for speaker engagements: Advicciene, Alexion, Astellas, AstraZeneca, Amicus, Amgen, Bayer, Chiesi, Fresenius Medical Care, Idorsia, Kyowa Kirin, Menarini, Otsuka, Sanofi Genzyme, and Vifor Fresenius Medical Care Renal Pharma. S. Sinha reports consultancy agreements with Sanifit; research funding from Amgen, AstraZeneca, and Ethicon; and honoraria from AstraZeneca, Bayer, Napp Pharmaceuticals, Novartis, and Sanofi Genzyme. M.F. Slon-Roblero reports consultancy agreements with Baxter, Fresenius, and Nipro; and honoraria from Baxter, Fresenius, and Nipro. M.J. Soler reports consultancy agreements with AstraZeneca, Bayer, Boehringer, Esteve, Jansen, Mundipharma, Novo Nordisk, Travere, and ICU; research funding from Abbvie and Boehringer; honoraria from AstraZeneca, Boehringer, Esteve, FMC, Jansen, ICU Medical, Mundipharma, Novo Nordisk, Otsuka, and Travere; patents and inventions: U691ES00; is a scientific advisor for or member of BMC Nephrology and Clinical Kidney Journal; is a former member of ERA-EDTA Council; participates in a speakers’ bureau for AstraZeneca, Bayer, Boehringer, Esteve, FMC, Jansen, Mundipharma, Novo Nordisk, and Vifor; is a member of the Sociedad Española de Nefrología and Sociedad Catalana de Nefrologia; and is elected editor-in-chief of the Clinical Kidney Journal. All remaining authors have nothing to disclose., (Copyright © 2022 by the American Society of Nephrology.)

Background: In order to expand the pool of usable donors from circulatory death (DCD) there is increasing interest in normothermic regional perfusion (NRP) to assess and improve liver viability. 1,2 NRP may also improve outcomes in kidney transplantation.We present our single center experience of outcomes in imported kidneys following NRP., Methods: Data was obtained from a prospectively maintained database between December 2012 and September 2018. Primary endpoints were incidence of delayed graft function (DGF) and estimated glomerular filtration rate (eGFR)., Results: Six-hundred and thirty-two decease donor kidneys were transplanted, 229 from DCD donors, 29 of which had NRP. The DGF rate was lower for NRP versus DCD (six of 29, 20.7% vs. 70 of 200, 35.0%) with reduced duration of DGF. Multivariate analysis demonstrated transplant type to be a statistically significant independent predictor of eGFR at 7 and 14 days. Early transplant function in NRP kidneys was comparable to DBD. There were no graft losses within 30 days in the NRP group. One-year graft loss rate was 3.4% for NRP and 6.0% for standard DCD., Conclusion: This data suggests NRP is safe, and reduces rates of DGF and improves early renal transplant function., (© 2021 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)